On 5 January 2017, Pfizer claimed that their REFLECTIONS B538-02 study of monoclonal antibody, PF-06410293, met its primary objective. The company reported that this potential biosimilar of Humira demonstrated equivalent efficacy for treatment of those with severe active rheumatoid arthritis, as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12.

The study was designed to evaluate the safety, efficacy and immunogenicity of PF‑06410293 versus the originator biological (Humira), in combination with methotrexate administered subcutaneously to treat patients with moderate to severe active rheumatoid arthritis, who had had an inadequate response to methotrexate therapy. The multinational, randomized, double-blind, two-arm, parallel group equivalence study included 597 patients and set out to be both comparative and confirmatory.

Both Humira and the potential biosimilar, PF-06410293, are monoclonal antibodies. Humira is currently approved for multiple indications in the US and other markets across the globe. Indications include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. As the highest grossing pharmaceutical of past years, and with a US patent that expired in 2016 [2], Humira faces potential competition from biosimilars under development. Amgen’s biosimilar version of Humira, Amjevita, received US Food and Drug Administration (FDA) approval in September 2016 [3], but they will not release the product on to the US market until ongoing patent litigation with AbbVie is resolved.

Pfizer reported that, at present, PF-06410293 has not received regulatory approval in any country, nor has its biosimilarity been claimed or established by regulatory authorities. However, the company claimed that this announcement, reporting top-line results of a potential biosimilar, is the second for a proposed inflammation biosimilar and the third for a proposed biosimilar pipeline molecule, since autumn 2016. The company also claimed that their biosimilars pipeline currently consists of eight distinct biosimilar molecules in mid to late stage development, and several others in earlier stages of development. These developmental compounds could join Pfizer’s, Inflectra, a biosimilar version of Remicade (infliximab) and the first biosimilar monoclonal antibody approved in the US [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
2. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
3. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Pfizer to launch infliximab biosimilar Inflectra in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-launch-infliximab-biosimilar-Inflectra-in-US

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